BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SHOULDER CUSTOM AUGMENT

    MDR report key: 5123341 · Received October 2, 2015

    Report

    Report Number
    1822565-2015-02066
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Date of Event
    August 27, 2015
    Report Date
    August 27, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    KWR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICE USED: CATALOG #32855091031, ZIMMER SHOULDER CUSTOM AUGMENT, LOT #95006410. ONLY THIS COMPONENT WAS RETURNED FOR EVALUATION ON 09/30/2015. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    AS RETURNED THE AUGMENT BLOCK IS IN LIKE NEW CONDITION, AND THE RETURNED PACKAGING MATERIAL INDICATES A 15 DEGREE AUGMENT. THE RETURNED AUGMENT BLOCK MEASURES AS A 30 DEGREE DEVICE. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THE DEVICE WAS USED FOR TREATMENT. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE AS INCORRECTLY RETRIEVING THE PROGRAM FOR PRODUCTION OF THE CUSTOM IMPLANTS. AS THESE ARE CUSTOM DEVICES, THEIR PROGRAMS WERE NOT STORED IN THE SAME MANNER AS STANDARD PRODUCTION, CONTROLLED DOCUMENTS. THE WRONG PROGRAM WAS RUN FOR THE PART NUMBER. ADDITIONALLY THE INSPECTION PLANS FOR CUSTOM DEVICES CONSISTS OF A MARKED UP DRAWING PROVIDED BY CUSTOM DEVELOPMENT. IN THIS CASE THE INSPECTION DIMENSIONS CITED ON THE DRAWING DID NOT DIFFERENTIATE BETWEEN THE 15 DEGREE AND 30 DEGREE COMPONENTS. THEREFORE, THE ISSUE WAS IDENTIFIED IN INSPECTION. AS AN OUTPUT OF THIS INVESTIGATION, CUSTOM DEVICE PROGRAMS ARE NOW PLACED IN THE SAME CONTROLLED LOCATION AS STANDARD PRODUCTION PROGRAMS, AND UPDATED PRINTS WITH DIFFERENTIATED MEASUREMENTS WERE PROVIDED FOR INSPECTION. THIS ISSUE RESULTED IN A FIELD ACTION IN AUSTRALIA ONLY TO RETRIEVE THE AFFECTED LOTS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT CUSTOM MADE AUGMENTS WERE PACKAGED INCORRECTLY. A 15 DEGREE LARGE AUGMENT WAS ORDERED; HOWEVER, A 30 DEGREE LARGE AUGMENT WAS IN THE BOX. WHEN THE 30 DEGREE LARGE AUGMENT BOX WAS OPENED, THE 15 DEGREE LARGE AUGMENT FELL OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654561 ZIMMER SHOULDER CUSTOM AUGMENT SHOULDER PROSTHESIS KWR ZIMMER INC 95006411

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR